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Brief Title: Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Official Title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Study ID: NCT03319940
Brief Summary: A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Detailed Description: This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
Yale New Haven Hospital, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic, Columbus, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Cancer Pavillion, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Chris OBrien Lifehouse, Camperdown, New South Wales, Australia
Medizinische Universitaet Graz, Graz, , Austria
Landeskrankenhaus Salzburg, Salzburg, , Austria
Gustave Roussy, Villejuif, , France
Universitaetsklinikum Wuerzburg, Wuerzburg, , Germany
Prince of Wales Hospital, Shatin, New Territories, , Hong Kong
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital, Wakayama-shi, Wakayama, Japan
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Maastricht Universitair Medisch Centrum, Maastricht, , Netherlands
Biokinetica SA, Jozefow, , Poland
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina, Otwock, , Poland
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital St Gallen, Sankt Gallen, , Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation, Taoyuan, , Taiwan
Christie Hospital, Manchester, , United Kingdom
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR